NA 02.231.242Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982062130), received between Mar 19, 2021 and May 9, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K083025, K110354); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON THEN ADDRESSED THE NONUNION SITE, AND PLACED 2 NEW PLATES ONTO THE PATIENT'S FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN PATIENT'S FEMUR. THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/42MM THIS IS REPORT 9 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16897042 ↗
• InjuryMay 9, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON THEN ADDRESSED THE NONUNION SITE, AND PLACED 2 NEW PLATES ONTO THE PATIENT'S FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN PATIENT'S FEMUR. THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/42MM. THIS IS REPORT 8 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16897033 ↗
• InjuryMay 9, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON THEN ADDRESSED THE NONUNION SITE, AND PLACED 2 NEW PLATES ONTO THE PATIENT'S FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN PATIENT'S FEMUR. THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/42MM. THIS IS REPORT 1 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16896941 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2021 THE PATIENT UNDERWENT REVISION DUE TO MALUNION OF DISTAL FEMUR. THERE WAS NO SURGICAL DELAY REPORTED. THERE WERE FRAGMENTS GENERATED AND IT IS UNKNOWN IF THEY REMOVE EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/42MM THIS REPORT IS 1 OF 10 (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 11528533 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083025, K110354. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2014 · Feb 5, 2014 · Terminated
  Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
• Z-0401-2014 · May 29, 2013 · Terminated
  Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra